eTMF in clinical trials

eTMF – complete 24/7 visibility into all your trial documentation

Product sheet PDF

ISO 9001-2015 label certification new version

Have a helicopter view of eTMF processes at any point of time

Get instant safe access to your trial documentation from any place in the world.
See missing documents, files uploaded statistics, folder completeness by milestone or any other parameter.
Focus on the most relevant tasks with automated to-do lists, flexible widgets, and exportable reports.

Product sheet PDF

TMF Dashboard

General

My Favourites

Tools designed for your daily activities

Upload documents in seconds – email a document directly into eTMF or through an app on your phone, or drag and drop into eTMF, connect your computer through WebDAV or just browse and upload
Anything you prefer and used to works. eTMF integrated with CTMS, all CTMS documents are filed in eTMF with zero effort from you
Need one place to review, assign metadata and distribute documents to a correct folder? We got you covered with eTMF Manager space
Need to send documents in bulk to sites? Email it from eTMF with a track record
Review, approve, lock, sign, author documents with embedded eSignature function

TMF Manager

eSignature

Admin area

Simplicity without compromising quality

Periodic review of eTMF is finally easy with My views tab to choose a list of documents for review and use inbuilt chat function to query and correct a document
Inspection readiness is not a challenge anymore – it is a daily state of your eTMF
Regulations are met, validation is complete, audit trail is there
Archiving function, logs and external access designated for inspectors, auditors, partners is there too
No excessive training required

My Views

Archiving

Permissions

Power Your eTMF with AI

AI assigns the correct metadata to documents, ensuring they are filed accurately.
Stay compliant effortlessly – AI files your documents with accurate metadata.
AI works continuously, processing documents as soon as they are uploaded.
We protect your data by running AI on separate, local servers within your region – EU, US, or elsewhere – never in the public cloud. Encrypted connections and dedicated processing queues ensure your data stays private, secure, and never mixed with anyone else’s. Your information stays under your control at all times.
We provide thorough validation support, including validation of the AI models for guaranteed compliance.

Features

Simple TMF template creation and configuration, including DIA Reference Model
E-mail blasts from TMF to sites
OCR – system recognizes text in pictures, scans, photos
Online viewing and authoring via browser without download
Email alerts
Flexible access matrix

Web-based: no installation needed
The system can be hosted both cloud-based and on-premise
Single sign-on functionality is available using LDAP and SAML protocols
API is available for use in bidirectional integrations
System recognizes special /foreign characters

21 CFR Part 11 compliant
Access control, based on project role, sites, folders, countries and for external users
Full Audit Trail and versioning

Easy archiving of eTMF project with index and audit trail
GDPR-compliant
Fully validated, all related documentation is provided

Automated filing of documents from CTMS
Email upload – send email with attachment directly to eTMF
Batch documents upload and download

Drag and drop function
TMF connected as an external drive through WebDAV protocol
Mobile application

Adjustable notifications and alerts
My Views section – user-defined lists of documents based on metadata groups
QC Workflow for all file types, folders and placeholders

Chat and comments available for documents and folders
Documents review, approve, lock, sign configurable workflow and electronic signature

Real-time statistics on folders completeness
Business Intelligence: widgets and reports

Ad-hoc reporting tool for cross-project & cross-module reporting
Powerful search engine by various parameters in name and file content

Custom metadata setup and management
Various metadata structures templates

Metadata actions (e.g. notification on expiry date of the document)
Dynamic metadata reports

What They Say About Us

Tameo Kobayashi

Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.

Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.

Joshua Baisley, H.B.Sc.

VP, Clinical Design and Delivery

As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

John Douglas Snowden

Senior Vice President of Technology Innovation at NCGS, Inc.

NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Have questions?

Drop us a line and we be happy to answer all your questions

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

More about eTMF

July 31, 2025

How Much ROI Can You Expect from eTMF and CTMS?

A Comparative Look at Europe vs. US Markets In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

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June 19, 2025

Checklist: Migrating from a Legacy TMF to an eTMF

Many clinical trial teams still rely on a legacy TMF – whether that means physical binders or outdated digital folders lacking structure and traceability. These systems often fall short in today’s increasingly regulated, fast-paced environment, making oversight and compliance more difficult. That’s why more sponsors and CROs are transitioning to a modern eTMF. A modern […]

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May 15, 2025

How to Choose the Right eTMF Model

An electronic Trial Master File plays a central role in maintaining oversight, ensuring regulatory compliance, and supporting successful inspections by health authorities. An efficient eTMF is no longer optional – it’s essential. Choosing the right eTMF model for your clinical studies directly impacts how effectively your teams can manage documentation, maintain version control, and collaborate […]

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April 29, 2025

Use Case: Saving Time and Cost with AI in TMF Document Management

A mid-sized CRO managing 9,500 TMF documents annually faced increasing challenges with filing and metadata assignment. Each document required an average of 5–6 minutes to process manually. The Problem Manual document upload and metadata entry amounted to: This process also posed risks of human error and inconsistency. The Solution The CRO implemented an AI-powered eTMF […]

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See all the stories

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.